Drugs.com - New Drug Approvals
New drug approvals news from Drugs.com. Comprehensive, up-to-date drug news for consumers and healthcare professionals.
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FDA Approves Inluriyo (imlunestrant) in Combination with Verzenio (abemaciclib) for Adults with ER+, HER2-, ESR1-Mutated Advanced or Metastatic Breast Cancer
INDIANAPOLIS, Sept. 18, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has granted full approval to Inluriyo (imlunestrant), an oral estrogen receptor (ER) antagonist, in... -
IntraBio Announces U.S. FDA Approval of Aqneursa (levacetylleucine) for Ataxia-Telangiectasia
AUSTIN, Texas--(BUSINESS WIRE) September 18, 2026 --IntraBio Inc., a leader in the discovery, development, and commercialization of novel therapies for rare and common neurodegenerative diseases, today announced that the U.S. Food and Drug... -
FDA Approves Fayuvi (rebisufligene etisparvovec-hopf) Gene Therapy for the Treatment for Sanfilippo Syndrome Type A (MPS IIIA)
NOVATO, Calif., Sept. 17, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the U.S. Food and Drug Administration (FDA) granted standard full approval of Fayuvi (rebisufligene etisparvovec-hopf), also known... -
Bayer’s Kerendia (finerenone) Receives FDA Approval as the First New Treatment in 30 Years for Adults with Chronic Kidney Disease (CKD) and Type 1 Diabetes
September 17, 2026 -- Bayer today announced that the U.S. Food and Drug Administration (FDA) approved Kerendia® (finerenone) to reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce the risk of sustained estimated... -
Nuvation Bio Announces FDA Approval of Supplemental New Drug Application for Ibtrozi (taletrectinib) with Updated Duration of Response in TKI-Naïve Advanced ROS1-Positive Non-Small Cell Lung Cancer
NEW YORK, Sept. 16, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has approved... -
FDA Approves Reduced Monitoring Time for First Two Doses of Imdelltra
THOUSAND OAKS, Calif., Sept. 14, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) approved an update to the Imdelltra (tarlatamab-dlle) Prescribing Information that substantially reduces... -
Biofrontera Announces FDA Approval of Ameluz Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma
WOBURN, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today... -
FDA Approves Bexlutry (lutetium Lu 177 dotatate) for Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors
Boston, MA – 14 September, 2026 – Curium™ announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Bexlutry™ lutetium Lu 177 dotatate injection for the treatment of...